Device and method for electrical isolation of the pulmonary veins

• US 20040167598A1
• Filed: 11/06/2003
• Published: 08/26/2004
• Est. Priority Date: 11/08/2002
• Status: Active Grant

• Current Assignee: James R. Margolis
• Original Assignee: James R. Margolis
• Inventors: Margolis, James R.
• Granted Patent: US 7,192,438 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

Abstract

A method and device for the treatment of atrial fibrillation by inhibiting the flow of electricity from the pulmonary vein to the left atrium. The method includes inhibiting electrical flow by disabling the conductive fibers mechanically, using an incision (70), or via fibrosis, or chemically by applying toxic substances to the fibers. In one embodiment, a device (30) is useable to deliver a prosthetic structure (10) to the pulmonary vein that is useable to stretch the pulmonary vein, thereby inducing fibrosis, keeping the incision (70) open, or delivering a substance to the endothelium of the pulmonary vein. The structure (10) delivered by the device (30) is a self-expanding prosthetic structure. In another embodiment, a device (60) is useable to deliver and expand a prosthetic structure (10) that is expandable but not self-expanding.

Claims

1. A method of treating arterial fibrillation, comprising:

circumferentially cutting the endothelium of the pulmonary vein at a location proximate the left atrium;

delivering a prosthetic structure to the location of the cut, the structure constructed and arranged to keep the cut open, thereby preventing the endothelium from reestablishing electrical communication between the pulmonary vein and the left atrium.

2. The method of claim 1 further comprising expanding the prosthetic structure.

3. The method of claim 1 wherein circumferentially cutting the endothelium of the pulmonary vein at a location proximate the left atrium comprises:

placing a cutting balloon in operable proximity to the location;

inflating the cutting balloon until a circumferential cut is effected in the endothelium of the pulmonary vein; and

,

deflating the cutting balloon.

4. The method of claim 1 wherein delivering a prosthetic structure to the location of the cut comprises implanting a stent at the location of the cut.

5. The method of claim 1 wherein delivering a prosthetic structure to the location of the cut comprises implanting an expandable ring at the location of the cut.

6. The method of claim 1 wherein delivering a prosthetic structure to the location of the cut comprises:

placing a guidewire in a position to be used to guide a device to the location;

advancing a delivery device carrying the prosthetic structure over the guidewire to the location, such that the prosthetic structure is disposed circumjacent to the incision;

retracting a retractable sheath covering the prosthetic structure, thereby exposing the prosthetic structure to the incision;

expanding the prosthetic structure.

7. The method of claim 6 wherein expanding the prosthetic structure comprises allowing the prosthetic structure to self-expand.

8. The method of claim 6 wherein expanding the prosthetic structure comprises expanding the prosthetic structure mechanically.

9. A method of treating atrial fibrillation comprising:

advancing a delivery device having an atraumatic tip and a prosthetic structure to a location in the pulmonary vein of a patient, proximate the ostium to the left atrium;

deploying the prosthetic structure, thereby inhibiting the flow of electricity between the pulmonary vein and the left atrium.

10. The method of claim 9 wherein advancing a delivery device having an atraumatic tip and a prosthetic structure to a location in the pulmonary vein of a patient, proximate the ostium to the left atrium comprises:

percutaneously placing a guidewire at the desired location;

advancing the delivery device along the guidewire until the atraumatic tip has past the location; and

,

inflating a tapered balloon to secure the device at the location and to center the device in the pulmonary vein.

11. The method of claim 10 wherein deploying the prosthetic structure, thereby inhibiting the flow of electricity between the pulmonary vein and the left atrium comprises:

retracting a sheath, thereby exposing the prosthetic structure;

expanding the prosthetic structure, thereby stretching the pulmonary vein.

12. The method of claim 11 wherein expanding the prosthetic structure comprises allowing the prosthetic structure to self-expand.

13. The method of claim 11 wherein expanding the prosthetic structure comprises expanding the prosthetic structure mechanically.

14. A device useable to deliver a prosthetic structure to the pulmonary vein of a patient for the treatment of atrial fibrillation, comprising:

a catheter assembly having an atraumatic tip;

a balloon, operably attached to the catheter assembly for inflation and deflation thereby; and

,

a prosthetic structure, releasably attached to the catheter assembly.

15. The device of claim 14 wherein the balloon comprises a tapered balloon useable to assist in locating the catheter assembly in the pulmonary vein when inflated.

16. The device of claim 14 wherein the balloon comprises a cutting balloon, useable to make a circumferential incision in the pulmonary vein to inhibit the flow of electrical current between the pulmonary vein and the left atrium.

17. The device of claim 14 further comprising a deployment balloon, operably attached to the catheter assembly and disposed within the prosthetic structure and useable to expand the prosthetic structure.

18. The device of claim 14 further comprising a retractable sheath, slidingly disposed over the prosthetic structure.

19. The device of claim 18 wherein the prosthetic structure is self-expanding such that, when the retractable sheath is retracted, the prosthetic structure expands, attaching itself to the pulmonary vein. 20. The device of claim 14 further including a central lumen for accepting a guidewire therethrough.